PRIYAL COLD ICE ANALGESIC GEL- menthol gel 
Priyal Cosmetics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Priyal Cold Ice Gel

Active Ingredient

Menthol 2.0%

Purpose

Topical Analgesic

Uses:

Warnings

FOR EXTERNAL USE ONLY

Do not use:

When using this product

Stop use and ask a doctor if

If pregnant or breastfeeding

ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

If swallowed get Medical Help or contact a Poison Control Center right away

Directions

Inactive Ingredients

ammonium hydroxide, carbomer, cupric sulfate, FD&C Blue No. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

Drug Fact Panel

PRIYAL COLD ICE ANALGESIC GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72822-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.54 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CUPRIC SULFATE (UNII: LRX7AJ16DT)  
THYMOL (UNII: 3J50XA376E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72822-303-12227 g in 1 JAR; Type 0: Not a Combination Product04/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/08/2019
Labeler - Priyal Cosmetics (675482356)

Revised: 7/2020
Document Id: ab0bd6bf-df2d-66c9-e053-2995a90af5b5
Set id: ab0bdcc7-146e-c65e-e053-2995a90a3bda
Version: 1
Effective Time: 20200722
 
Priyal Cosmetics